Evaluation of the effects of lyophilization and post-reconstitution stability of plasma samples containing PT, APTT, and Fibrinogen parameters

Abstract

Objective: To evaluate the effects of lyophilization and post-reconstitution stability of plasma samples containing PT (Prothrombin Time), aPTT (activated Partial Thromboplastin Time), and fibrinogen parameters. Research method: Experimental study was conducted on lyophilized plasma samples containing PT, aPTT, and fibrinogen parameters. The homogeneity of sample set before and after lyophilization was evaluated, then the stability of the sample set was assessed in variable time and temperature reservation conditions by Paired–samples t–test. Results: Plasma samples containing 3 parameters PT, aPTT and fibrinogen were not significantly affected by the lyophilization process, shown through repeated measurements with p-value of 0.912, 0.699 and 0.334 respectively. Lyophilized plasma samples after reconstitution are stored at -20°C to achieve stability for 8 weeks, at 2 - 8°C stable for 24 hours, at laboratory temperature stable for 8 hours with all PT, aPTT, and fibrinogen parameters. Conclusion: The freeze-drying process does not change the values of PT, aPTT, fibrinogen parameters in plasma samples, so it can be applied to produce coagulation proficiency testing samples by lyophilization. The reconstituted sample is stable in different time and reservation conditions, met the requierment of reservation condition of reconstituted sample. Key words: Lyophilization, reconstitution, PT, aPTT, fibrinogen.